Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Tre… (NCT06088290) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
United States, Austria, Belgium469 participantsStarted 2023-09-21
Plain-language summary
The primary objective of this phase III trial is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntary signed and dated written informed consent of the participants obtained before any trial-specific procedure.
. Age ≥ 18 years.
. Histologically confirmed diagnosis of metastatic LMS, in participants not candidates for curative resection.
. Radiologically measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
. No previous systemic therapy for metastatic disease (i.e., first-line setting) and no previous anthracyclines. Note: prior chemotherapy (without anthracycline) in the context of adjuvant or neoadjuvant therapy is allowed. Prior line/s of hormone therapy in the adjuvant/metastatic setting are also allowed.
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate hematological, renal, metabolic and hepatic function:
. Hemoglobin ≥ 9.0 g/dL (participants may have received prior red blood cell \[Red Blood Cell\] transfusion); absolute neutrophil count (ANC) ≥ 2.0 x 10\^9/L, and platelet count
Exclusion criteria
. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
. Known low grade leiomyosarcoma (i.e., grade I).
. Known hypersensitivity to any of the components of the IV formulation of lurbinectedin or doxorubicin.
. Concomitant diseases/conditions:
. History of cardiac disease: myocardial infarction or angina within the year prior to enrollment; severe vascular disease; or symptomatic arrhythmia despite ongoing treatment.
. Participants with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV).
. Known chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.